By Lisa M. Campbell and Lisa R. Burchi
On November 21, 2018, in Court of Justice of the European Union (EU), the Fourth Chamber of the General Court (General Court/Fourth Chamber) issued a judgment in the appeal case T-545/11 RENV that denied all three pleas on appeal and prevented applicants Stichting Greenpeace Nederland and Pesticide Action Network Europe (Applicants) from receiving certain documents containing confidential information relating to the first authorization of the placing of glyphosate on the market as an active substance, specifically the complete list of all tests submitted by the operators seeking the inclusion of glyphosate in Annex I to Directive 91/414.
The judgment provides a detailed history of the case, beginning in 2010, when Applicants requested access to the documents in question. In this initial case, the Secretary General of the Commission agreed with the Federal Republic of Germany’s decision to refuse access to the documents (contested decision) on the basis that disclosure in Article 4(2) of Regulation No. 1049/2001 would undermine protection of the commercial interests of a natural or legal person. In upholding Germany’s decision, the Secretary General found that there was “no evidence of an overriding public interest in disclosure” within the meaning of Article 4(2) of Regulation No. 1049/2001, and also that the information “did not relate to emissions into the environment” within the meaning of Article 6(1) of Regulation No. 1367/2006 concerning public disclosure of information on the environmental effects of glyphosate. As such, “protection of the interests of the manufacturers of that substance had to prevail.”
The Applicants brought an action for annulment of the contested decision to the Registry of the General Court. After one of the documents at issue (a draft assessment report issued by Germany prior to the initial inclusion of glyphosate in Annex I to Directive 91/414) was produced to the court (but still not released to the Applicants), the General Court ruled to annul the contested decision. The Commission appealed this annulment, stating that the General Court erred in its interpretation of the term “information [which] relates to emissions into the environment.” The Court of Justice was persuaded by this argument, set aside the initial judgment, and referred the case back to the General Court. The case was then assigned to the Fourth Chamber. The dispute was limited to the part of the document at issue that “contains information on the degree of purity of the active substance, the ‘identity’ and quantities of all the impurities present in the technical material, the analytical profile of the batches, and the exact composition of the product developed.”
The Applicants put forward three pleas in law in support of their action. The pleas, and the basis for the General Court/Fourth Chamber’s rejections of those pleas, are as follows:
- Failure to Take Account of the Scope of Article 4(5) of Regulation No. 1049/2001: Article 4(5) of Regulation No. 1049/2001 provides that a Member State may request an institution not to disclose a document originating from that State without its prior agreement. Applicants submitted that Article 4(5) of Regulation No. 1049/2001 does not constitute a right of veto for a Member State and that the Commission may not rely on the Member State’s opinion regarding the application of an exception provided for by Article 4(2) of that Regulation. The General Court/Fourth Chamber stated that “the argument put forward cannot succeed, since Article 4(5) of Regulation No 1049/2001 is not the basis on which the Commission refused access to that document. Consequently, the first plea in law must be rejected.” Instead, Article 4(2) was the basis for Germany’s decision, and the Commission verified that Germany’s reasons for that decision were “prima facie, well founded.”
- Overriding Public Interest In Disclosing Information Relating to Emissions Into the Environment: Applicants maintained that the exception to the right of access designed to protect the commercial interests of a natural or legal person must be waived, because of an overriding public interest in disclosure of the information requested, which relates to emissions into the environment. Specifically, Applicants argued that information related to the identity and quantity of impurities present in glyphosate and related test information must be disclosed so that it could be determined “which toxic elements are emitted into the environment and are liable to remain there for some time.” With regard to the concept of “information relating to emissions into the environment,” the General Court/Fourth Chamber rejected arguments that the provision must be interpreted restrictively to mean only direct or indirect release of substances from installations. The General Court/Fourth Chamber also found, however, that the concept cannot be interpreted in a way that would “deprive of any practical effect the possibility” that a Member State could refuse to disclose environmental information or “jeopardise the balance which the EU legislature intended to maintain between the objective of transparency and the protection of [commercial] interests.” In rejecting the second plea, the General Court/Fourth Chamber states:
Since the use, the conditions of use and the composition of a plant protection product authorised by a Member State on its territory may be very different from those of products evaluated at EU level during the approval of the active substance, it must be held that the information in the document at issue does not relate to emissions whose release into the environment is foreseeable and has, at the very most, a link to emissions into the environment. Accordingly, such information is excluded from the concept of “information relating to emissions into the environment,” in accordance with paragraph 78 of the judgement on appeal.
- Alleged Infringement of Article 4(2) of Regulation No. 1049/2001 and Article 4 of the Aarhus Convention: Applicants argued that the contested decision is not in accordance with Article 4(2) of Regulation No. 1049/2001 and Article 4 of the Aarhus Convention, on the ground that the Commission did not evaluate the actual risk of damage to the commercial interests invoked. The General Court/Fourth Chamber stated that it must be held “that the Commission correctly weighed up the relevant interests, having set out precisely and specifically the way in which the commercial interests of producers of glyphosate or plant protection products containing it would be jeopardised by the disclosure of the document at issue.”
After rejecting all three pleas, the General Court/Fourth Chamber held that the action must be dismissed in its entirety, and ordered Applicants to pay the costs relating to the various proceedings.
This case has been monitored closely because of the potential implications for companies that have submitted data or other information claimed as confidential that could be disclosed based on “overriding public interest.” The American Chemistry Council (ACC), CropLife America, CropLife International (CLI), the European Chemical Industry Council (Cefic), the European Crop Care Association (ECCA), the Association européenne pour la protection des cultures (ECPA) and the National Association of Manufacturers (NAM) all intervened in support of the form of the order sought by the Commission. The decision, and, in particular, the limitations placed on the scope of what is to be considered “information on emissions into the environment” provides helpful guidance and ensures that the exceptions provided for disclosure do not swallow the general rules under which institutions must refuse access to documents.
More information on glyphosate issues is available on our blog.
By Lisa M. Campbell and Heather F. Collins, M.S.
On November 19, 2018, the U.S. Environmental Protection Agency (EPA) announced that the U.S.-Canada Regulatory Cooperation Council (RCC) Stakeholder Forum will take place on December 4, 2018, from 12:00 p.m. to 5:15 p.m. (EST) and on December 5, 2018, from 9:00 a.m. to 5:00 p.m. (EST) at the Washington Convention Center, 801 Mt. Vernon Place, in Washington, D.C. The RCC brings together senior regulatory officials, industry, and other members of the public from both sides of the U.S.-Canada border to promote economic growth, innovation, competitiveness, and job creation through the elimination of unnecessary regulatory differences between the U.S. and Canada. Canadian and U.S. regulators will provide progress reports on existing regulatory cooperation efforts and solicit public input on new opportunities for regulatory cooperation.
During the forum, EPA’s Office of Pesticide Programs (OPP) and Canada’s Pest Management Regulatory Agency (PMRA) will lead a breakout session that will include updates on the successes of the 2016 work plan and cooperation between the two agencies pertaining to pesticide registration. The U.S. and Canadian agencies are working together to:
- Collaborate on a bilateral pesticide re-evaluation for three neonicotinoid pesticides (i.e., imidacloprid, thiamethoxam, and clothianidin) employing a new pollinator risk assessment framework;
- Develop best practices for coordinated work planning for the re-evaluation of registered pesticides;
- Develop new and/or alternative approaches to testing and assessment, including reducing the need for animal testing wherever possible;
- Align pesticide residue trial requirements by prospectively determining the number of residue field trials required for joint registrations; and
- Jointly develop information technology solutions that facilitate the submission of applications to either regulatory authority.
Additionally, both offices hope to hear feedback from stakeholders to help inform a new three-year pesticide programs work plan for 2019-2021.
Specific times for this and other breakout sessions, as well as more detail, will be made available online. The Stakeholder Forum is open to the public, with advance registration. Space is limited and registrations will be accepted on a first-come-first-served basis. Registration is available online.
By Carla N. Hutton
On April 10, 2018, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft Science Policy document intended to reduce the use of animals in testing chemicals to evaluate whether they cause an allergic reaction, inflammation, or sensitization of the skin. According to EPA, the document, Draft Interim Science Policy: Use of Alternative Approaches for Skin Sensitization as a Replacement for Laboratory Animal Testing, “describes the science behind the non-animal alternatives that can now be used (in vitro, in silico, in chemico) to identify skin sensitization.” The draft Science Policy states that the Office of Pesticide Programs (OPP) and Office of Pollution Prevention and Toxics (OPPT) will immediately begin to accept submissions of new approach methodologies (NAM) and defined approaches (DA) as described in the draft Science Policy. EPA notes that there are multiple domestic and international activities ongoing that will allow for refinement and expansion of this draft Science Policy to other DAs and additional NAMs and support global harmonization of DAs for skin sensitization. According to the draft Science Policy, OPP and OPPT “will continue to be active participants in these activities to ensure regulatory acceptance and will continue to support cross-sector collaborations that enhance animal welfare, and accelerate the implementation of NAMs.” Comments on the draft Science Policy document must be submitted to Docket Number EPA-HQ-OPP-2016-0093 by June 9, 2018.
The draft Science Policy is the result of national and international collaboration between the Interagency Coordinating Committee on the Validation of Alternative Methods, the National Toxicology Program’s Interagency Center for the Evaluation of Alternative Toxicological Methods, the European Union Reference Laboratory for Alternatives to Animal Testing, and Health Canada’s Pest Management Regulatory Agency.
By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi
Beginning on January 23, 2018, the European Commission (EC) opened a consultation period on the European Food Safety Authority (EFSA) risk assessment process (scientific advice). The EC states it is seeking feedback on its process both as a “follow-up to the commitments made by the Commission in reply to the European Citizens’ Initiative on glyphosate,” and in response to “citizens [that] have put into question the risk assessment based on studies provided by the industry and this in particular where the industry seeks an authorisation, e.g. for pesticides, GMOs etc.”
The General Food Law Regulation established EFSA, an independent scientific agency, to provide the risk assessment component of its risk analysis principle; the other two components are risk management and risk communication. EFSA provides its scientific opinions “which form the basis for the measures taken by the [European Union (EU)] in the food chain.” The EC states the General Food Law Regulation “is the cornerstone of the EU regulatory framework covering the entire food chain: ‘from farm to fork.’” The EC is requesting feedback to help it “look into how [the EC] can improve the current system and to address citizens’ expectations about independence and transparency of the EU risk assessment system.” The EC is specifically requesting views and experiences on the following:
- The transparency and independence of the EU risk assessment system with respect to the underlying industry studies and information on which EFSA's risk assessment/scientific advice is based;
- Risk communication; and
- The governance of EFSA, in particular the involvement of the EU Member States (MS) in the EU risk assessment system.
To contribute, interested parties must fill out the online questionnaire available here. All stakeholders and EU as well as non-EU citizens are welcome to contribute to this consultation. The consultation period will close on March 20, 2018.
This Consultation is of significant interest to stakeholders, particularly in balancing the potential need for increased transparency with the need to protect confidential business information, trade secret information, and proprietary expensive data investments. Decisions made by EFSA also could have a global impact on data protection, as any decisions made by EFSA to increase transparency could affect whether certain data can continue to be protected under other regulatory programs.
Outside of the transparency issues that are receiving much attention of late, it is important to note generally that views about risk assessment policies across governments tend to be driven by underlying political disagreements, with support or criticism somewhat predictable depending on how the resultant decisions are “for or against” the view of an interested constituency.
The transparency issue here should be considered not only on its own merits, but also within the controversy that surrounded the EU assessment approach for glyphosate, an herbicide which is widely used in production of genetically modified crops. As a stalking horse for the EU debate about biotechnology crops, the EU glyphosate assessment has, for example, become embroiled as part of the glyphosate carcinogenic classification of the International Agency for Research on Cancer (IARC). See our blog item IARC Announces Cancer Classification for Glyphosate and Other Pesticides. The IARC review concluded that glyphosate is a “probable human carcinogen,” contrary to most other assessments done by the U.S., Canada, and some EU Member States. Comments on the general EU risk assessment process can be expected to be intertwined with the perspective that any commenter has on the glyphosate assessment, even though the request is for public comment on the assessment process generally, and not only specifically about glyphosate.
More information on glyphosate is available on our blog under key word glyphosate.
By J. Brian Xu, M.D., Ph.D., DABT®
On September 29, 2017, the Ministry of Agriculture of China (MOA) issued the final revisions to Data Requirements on Pesticide Registration (MOA Proclamation No. 2569). The revisions will become effective on November 1, 2017, under the new Regulation on Pesticide Administration (RPA) and Pesticide Registration Management Measures (MOA Order No. 3, 2017). The draft revisions to Data Requirements on Pesticide Registration were initially released for public comment on June 30, 2017. The new Data Requirements include 10 chapters and 14 annexes and a category of pesticides for specialty minor crops has been added. More information on China’s new pesticide regulations is available in our blog under key word China.
MOA Order No. 3, 2017 requires chemistry and toxicology tests to be completed in laboratories located in China approved by the MOA or overseas laboratories that have a mutual recognition agreement with the relevant Chinese Authority. The new Data Requirements on Pesticide Registration do not provide any additional information about the acceptance of data generated in overseas laboratories.
It remains unclear whether, for example, for literature or data prepared in a foreign language, entire study reports/articles, or only summaries, must be translated into Chinese. In addition, the final revision of Data Requirements on Pesticide Registration deletes the category of “Pesticides for Overseas Uses Only” that was set forth in the draft revision of Data Requirements on Pesticide Registration.
The new RPA, MOA Order No. 3, 2017, and the Data Requirements on Pesticide Registration significantly change the registration requirements and the registration process for pesticides in China. These new requirements, and the many ambiguities they contain, will likely extend the time for obtaining registrations and impose additional challenges on manufacturers to overcome, particularly foreign manufacturers who wish to bring pesticide products to the Chinese market.
By J. Brian Xu, M.D., Ph.D., DABT®
On June 1, 2017, in the People’s Republic of China (China), a newly revised Regulation on Pesticide Administration (RPA) became effective. The newly revised RPA was approved during the 164th executive meeting of the State Council of China on February 8, 2017 and published as Decree Number 677 of the State Council of China (in Chinese only) (China Decree 677) on April 1, 2017.
The first version of the RPA became effective on May 8, 1997, and was revised on November 29, 2001, by China Decree 326. China Decree 677 makes significant changes to the current version of RPA (China Decree 326), and requires the Ministry of Agriculture (MOA) to formulate relevant rules and measures for its implementation. The revised RPA includes eight chapters: General Provisions; Pesticide Registration; Production of Pesticides; Distribution of Pesticides; Uses of Pesticides; Supervision and Management; Legal Liability; and Supplementary Provisions.
On March 17, 2017, the MOA released five implementation measures for public comments (in Chinese only) but did not provide an implementation date. The measures include: Pesticide Registration Management Measures (Draft); Measures for the Management of Pesticide Production License (Draft); Measures for the Administration of Pesticide Business License (Draft); Measures for the Administration of Pesticide Labels and Manuals (Draft); and Measures for the Management of Tests Used for Pesticide Registration (Draft).
The new RPA is intended to: streamline the administration process; implement licensing systems for pesticide production and distribution; promote the reduction of pesticide uses and enhance the management of highly toxic pesticides; clarify the responsibilities of manufacturers, sponsors of the contracted manufacturers, and distributors for the safety, efficacy, and quality of pesticides; establish pesticide recall and pesticide waste recycling systems; and prevent and punish the adulteration of pesticides. The new RPA also revises the registration process and labeling requirements of pesticides, removes temporary pesticide registration, includes increased fines and blacklisting, and requires that manufacturers and distributors/retailers of pesticides establish a tracking system and maintain the required records for at least two years.
The new RPA significantly changed registrations for pesticides in China. Temporary pesticide registration is no longer an option. There were two registration review committees: the Temporary Pesticide Registration Review Committee that held a review meeting every two months; and the Full Pesticide Registration Review Committee that held a review meeting every six months, before the new RPA became effective. The two committees are being replaced by the National Pesticide Registration Review Committee, but no frequency of review meetings was provided. It is expected that the National Pesticide Registration Review Committee will meet less frequently than once every two months, which may result in a longer timeline for review and approval. Without temporary pesticide registrations, a full set of data will be required with every pesticide registration, including two-year stability data in the initial submission. Therefore, the new pesticide registration process may extend the time for manufacturers to bring products to the Chinese market.
The new RPA requires the foreign registration of active ingredients; possibly new formulations will obtain the registration in another country before registering it in China.
In addition, the Pesticide Registration Management Measures (Draft) requires that chemistry and toxicology tests should be completed in laboratories approved by the MOA or overseas laboratories maintaining mutual recognition agreements with the Chinese Government and complying with Good Laboratory Practices (GLP), and that efficacy, residue, and environment tests shall be conducted in China. Since China is not a member country of the Organization for Economic Cooperation and Development’s (OECD) Mutual Acceptance of Data (MAD) system, this proposed requirement could reject all test reports from overseas for pesticide registration in China. It also requires that literature or data in a foreign language shall be translated to Chinese, but is not clear if the whole article/reports or only the summary should be translated into Chinese. The timeline for new data requirements on pesticide registration under the new RPA is not provided. Many questions for pesticide registration under the new RPA remain.
By Zameer Qureshi
On November 23, 2016, the European Court of Justice (ECJ) issued two landmark judgments in Case C-673/13 P (Commission v Stichting Greenpeace Nederland and Pan Europe) and Case C-442/14 (Bayer CropScience and Stichting De Bijenstichting v College voor de toelating van gewasbeschermingsmiddelen en biociden).
In Case C-673/13 P, the associations Stichting Greenpeace Nederland and Pesticide Action Network Europe (PAN Europe) submitted a request to the European Commission (EC) under Regulation (EC) No 1367/2006 for access to a number of documents relating to the initial marketing authorization for glyphosate, one of the most widely used herbicides in the world for agricultural weeding and the maintenance of urban and industrial areas. The EC granted access to the documents, with the exception of part of the draft assessment report prepared by Germany. The EC justified its refusal by stating that the document in question contained confidential information on the intellectual property rights of the applicants for the glyphosate authorization.
The associations brought an action before the General Court of the European Union (EU) for annulment of the EC’s decision. The General Court upheld that action in its judgment of October 8, 2013. The General Court considered that certain segments of the document in question contained information relating to emissions into the environment. Consequently, the EC was not entitled to invoke the confidentiality of commercial and industrial information, and “should have granted the associations access to those parts.” The EC was not satisfied with the judgment and asked the ECJ to set it aside.
In Case C-442/14, Bijenstichting, a Dutch bee protection association, submitted a request to the Netherlands’ authority responsible for authorizing the marketing of plant protection products and biocidal products (i.e., College voor de toelating van gewasbeschermingsmiddelen en biociden (CTB)) for disclosure of 84 documents concerning marketing authorizations issued by the authority. Bayer, a company holding a large number of these authorizations, objected to the disclosure on the basis that it would “infringe copyright and adversely affect the confidentiality of commercial or industrial information.” CTB authorized disclosure of 35 of the 84 requested documents because they contained information on emissions into the environment, “even though such disclosure could have an adverse effect on the confidentiality of commercial or industrial information.” Under Directive 2003/4/EC, commercial and industrial confidentiality may not be invoked to prevent disclosure of such information.
Bijenstichting and Bayer appealed CTB’s decision before the Netherlands courts, which referred several questions to the ECJ for a preliminary ruling regarding, among other things, whether the information requested by Bijenstichting falls within the concept of “information on emissions into the environment” -- with the consequence that it should be disclosed without Bayer being entitled to object on the grounds that such disclosure could adversely affect the confidentiality of commercial or industrial information.
The ECJ’s judgments clarify what must be understood by “emissions into the environment” and “information on [or which relates to] emissions into the environment” within the meaning of the Regulation applicable in Case C-673/13 P and the Directive applicable in Case C-442/14. In both judgments, the ECJ found that the concept of “emissions into the environment” includes the release into the environment of products or substances (e.g., plant protection products or biocides or active substances contained in those products) to the extent that the release is actual or foreseeable under “normal or realistic conditions of use of the product or substance.”
The ECJ concluded, therefore, that this concept is indistinguishable from the concepts of “release” and “discharge” and cannot be restricted to emissions emanating from industrial installations. The ECJ decided that the concept covers emissions resulting from spraying of a product into the air or its use on plants, in water, or in soil. Such limitations, the ECJ opined, would be “at odds with the objective of the regulation and directive for disclosing environmental information as widely as possible.” Additionally, the ECJ decided that Directive 2003/4/EC and Regulation (EC) No 1367/2006 cover information on actual and foreseeable emissions from a product into the environment. The ECJ concluded that “purely hypothetical emissions” are not covered by the laws.
The ECJ stated that the concept of “emissions into the environment” must be interpreted as covering not only information on emissions, but also information enabling the public to “check whether the assessment of actual or foreseeable emissions,” on the basis of which the Competent Authority authorized the product or substance in question, is correct.
In Case C-673/13 P, the ECJ set aside the judgment of the General Court insofar as the General Court considered that it is sufficient that information relates “in a sufficiently direct manner” to emissions into the environment for it to be covered by Regulation (EC) No 1367/2006. The ECJ referred the case back to the General Court of the EU for determination of whether the information at issue relates to emissions into the environment, and, if necessary, for ruling on the parties’ arguments that were not examined in its judgment. Case C-442/14 has also been referred back to the lower court.
The ECJ’s judgments clarify that public interest in “information on emissions into the environment” is important and oftentimes overrides commercial interests. The ECJ’s rulings have potentially significant and widespread implications for companies seeking to protect trade secrets and other sensitive information. The ECJ’s reasoning in its judgment can be applied to information submitted in relation to chemical products other than pesticides that are intended for uses that involve releases into the environment. The ECJ’s judgments have been criticized for not addressing risks of substantial harm to pesticide industry innovators and their proprietary rights if studies are now deemed subject to the EU’s disclosure mandate -- data developers will need to consider this possibility and take measures to protect their sensitive information.
By Lisa R. Burchi and Zameer Qureshi
On August 23, 2016, the European Chemicals Agency’s (ECHA) Board of Appeal (BoA) adopted its first decision on a data sharing dispute under the Biocidal Products Regulation (BPR).
Thor GmbH (Thor) lodged the appeal in 2015 after ECHA granted permission to a company to cite studies owned by Thor for the substance reaction mass of 5-chloro-2-methyl-2H-isohtiazol-3-one and 2-methyl-2H-isothiazol-3-one (CIT/MIT). According to ECHA, Thor had insisted on a technical equivalence assessment of its substance with the other company’s active substance to check if the companies’ substances had similar chemical composition and hazard profiles. ECHA stated this was not required under BPR and data owners “do not have the right to demand any form of similarity check as a prerequisite for getting a letter of access.”
The BoA ruled in favor of Thor, which raised five pleas in law, as the companies had mutually agreed to perform a technical equivalence assessment before sharing data. The BoA concluded that while ECHA “might be correct” in concluding that the technical equivalence assessment is not a legal requirement for data sharing under BPR, “this legal observation cannot constitute an assessment of the parties’ efforts to reach an agreement within the meaning of Article 63.” The BoA stated “it is part of the Appellant’s and the prospective applicant’s contractual freedom to insert a clause relating to a technical equivalence assessment in the data sharing agreement.”
The BoA also reviewed the negotiations between the parties to determine whether those parties make every effort to reach an agreement, and found that ECHA “did not consider all the relevant facts in a balanced manner when assessing whether every effort had been made by Appellant and the prospective applicant under Article 63.” The BOA found that ECHA disregarded some of Thor’s efforts based on its legal conclusion that there was no need to perform a technical equivalence assessment. Consequently, the BoA concluded that Thor had made every effort to reach an agreement with the other company and ECHA had failed to consider all the facts of the case.
Although ECHA’s decision was annulled, there remains a question whether a new decision is required. Since the BoA’s decision, the prospective applicant submitted a successful application under Article 95, which may negate the need for the prospective applicant to cite to Thor’s data. The case was remanded to ECHA to determine whether a new decision is required.
By Zameer Qureshi
The fourth Biocides Stakeholders’ Day took place on September 1, 2016, at the European Chemicals Agency’s (ECHA) headquarters in Helsinki, Finland. The event provided biocides stakeholders with information on the Biocidal Products Regulation (BPR) and the tools and support available. The focus was on experiences from companies, ECHA, and the European Commission (EC). ECHA stated “[t]he objective was to equip companies with information about their roles and obligations to meet the legal requirements for biocides.”
The program for the event included three plenary sessions. Plenary Session 1, “Challenges and Opportunities,” was commenced by ECHA’s Executive Director, Geert Dancet. Topics discussed in Plenary Session 1 included a “[r]egulatory update from the [EC],” “[a]ctivities in 2016,” and “Union [Authorization] in Practice.” Plenary Session 2 focused on “IT Tools and Dossier Preparation,” and included discussions on IUCLID 6 and R4BP 3. IUCLID 6 is used to collect, organize, and store data on active substances and biocidal products. Dossiers generated through IUCLID 6 are submitted to ECHA and national authorities through R4BP 3, “the central hub through which all biocides applications are made.” Plenary Session 3 on the “Enforcement of Biocidal Products” consisted of discussions on enforcement by the EC and Member States, and closed with a case study on “Enforcement from an Industry Perspective.”
The Plenary Sessions were followed by Questions and Answers, closing remarks from Jack De Bruun, ECHA’s Director of Risk Management, and an opportunity for attendees to meet the ECHA staff.
By Lisa M. Campbell and Lisa R. Burchi
On May 10, 2016, the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) issued guidelines on highly hazardous pesticides (HHP) (Guidelines) as part of the International Code of Conduct on Pesticide Management (Code of Conduct). HHPs are defined in the Guidelines as “pesticides that are acknowledged to present particularly high levels of acute or chronic hazards to health or environment according to internationally accepted classification systems such as WHO or GHS or their listing in relevant binding international agreements or conventions. In addition, pesticides that appear to cause severe or irreversible harm to health or the environment under conditions of use in a country may be considered to be and treated as highly hazardous.” The Guidelines state that they are “intended to help national or regional pesticide regulators with limited resources to design a process to address HHPs that follows the three steps of identification, assessment and mitigation,” and they aim “to underscore the importance of adequate pesticide legislation, and risk and needs assessment as part of the registration process.”
In 2006, the FAO Council endorsed FAO participation in the Strategic Approach to International Chemicals Management (SAICM) and noted that the International Code of Conduct on the Distribution and Use of Pesticides was to be considered an important element of the SAICM process. The Council “suggested that the activities of FAO could include pesticide risk reduction, including the progressive banning of Highly Hazardous Pesticides (HHPs).” The Joint FAO/WHO Meeting on Pesticide Management (JMPM) developed the criteria that defines HHPs when the Code of Conduct was revised in 2013.
In 2015, SAICM’s International Conference on Chemicals Management adopted a resolution recognizing “HHPs as an issue of concern and called for concerted action to address HHPs, with emphasis on promoting agro-ecologically based alternatives and strengthening national regulatory capacity to conduct risk assessment and risk management.”
2016 HHP Guidelines
The Guidelines include information on:
Identification of HHPs: The Guidelines set forth the following eight criteria for identifying HHPs (i.e., HHPs should be defined as having one or more of the following characteristics):
- Criterion 1: Pesticide formulations that meet the criteria of classes Ia or Ib of the WHO Recommended Classification of Pesticides by Hazard;
- Criterion 2: Pesticide active ingredients and their formulations that meet the criteria of carcinogenicity Categories 1A and 1B of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS);
- Criterion 3: Pesticide active ingredients and their formulations that meet the criteria of mutagenicity Categories 1A and 1B of the GHS;
- Criterion 4: Pesticide active ingredients and their formulations that meet the criteria of reproductive toxicity Categories 1A and 1B of the GHS;
- Criterion 5: Pesticide active ingredients listed by the Stockholm Convention in its Annexes A and B, and those meeting all the criteria in paragraph 1 of Annex D of the Convention;
- Criterion 6: Pesticide active ingredients and formulations listed by the Rotterdam Convention in its Annex III;
- Criterion 7: Pesticides listed under the Montreal Protocol; or
- Criterion 8: Pesticide active ingredients and formulations that have shown a high incidence of severe or irreversible adverse effects on human health or the environment.
Assessment: The Guidelines set forth guidance to assess the risks to human health and the environment under the conditions of use, as well as the needs for the products. FAO developed a Pesticide Registration Toolkit (Toolkit) to assists registrars in the evaluation for authorization of pesticides and review of registered pesticides. The Guidelines state:
- The Toolkit can best be considered as a web-based registration handbook intended for day-to-day use by pesticide registrars. It supports and facilitates informed decision-making by registrars, but is not an automated system that suggests decisions for registrars.
- Registrars can use the Toolkit to support several of their regular tasks. With respect to highly hazardous pesticides (HHPs), the Toolkit can be used as an aid to implement the three steps described in these guidelines: Identification, Assessment and Mitigation.
Mitigation: The Guidelines provide options for mitigating risks of HHPs currently in use, and for possible new HHPs. Specifically, the Guidelines state the “main lines for risk mitigation are ending, restricting or changing formulations or uses. Selection of the most appropriate option will vary from case to case and depend on risk levels and needs, but also on policies and adequacy of institutional infrastructure for pesticide management.”
Planning: The Guidelines set forth steps for designing an action plan to address HHPs. FAO and WHO note the importance of effective communication and involvement with stakeholders in the pesticide supply chain (e.g., growers, food retailers, consumers) in developing an action plan.
Prevention: The Guidelines discuss elements to prevent future problems with HHPs, particularly possible revision of the registration system, strengthened enforcement, extensive training, and the installation of surveillance systems.
Concerns have been raised previously regarding any potential for efforts by WHO and FAO to eliminate HHPs to be based purely on hazard without consideration of risk. The Guidelines include discussions related to the steps to “assess the risks that [HHP] products are posing to human health and the environment under the conditions of use in that country and to review the needs for these products, taking into consideration available alternatives.” Whether this provision sufficiently addresses past concerns should be examined.
Companies will need to review the Guidelines, and the Toolkit, to determine how their products would be identified, assessed, prioritized, and managed under the Guidelines and Toolkit. While some elements of the Guidelines are relatively straight-forward, others may be more subjective and thus much more controversial, such as, for example, the HHP criteria that a pesticide active ingredient or formulation has “shown a high incidence of severe or irreversible adverse effects on human health or the environment.” In addition, the Toolkit is under development, meaning that several modules are not completed and that webpages may not yet be completed. It, thus, will be important to continue to monitor how the Guidelines and Toolkit are developed and applied.